Devices and methods for tracking an energy delivery device

ABSTRACT

Methods for treating a network of organs including generating a map of at least a portion of the network of organs using a rendering system; selecting at least one treatment location within the luminal passageway of the network of organs; and applying an energy therapy to the treatment location to treat the smooth muscle tissue, where the energy therapy applied to the respective treatment location is defined by a plurality of parameters that are associated with a map. Such a system allows for historical or ideal treatment parameters to be identified, visually or otherwise to actual treatment locations. Also, control systems and methods for delivery of energy that may include control algorithms that prevent energy delivery if a fault is detected and may provide energy delivery to produce a substantially constant temperature at a delivery site. In some embodiments, the control systems and methods may be used to control the delivery of energy, such as radiofrequency energy, to body tissue, such as lung tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/725,576, filed on Mar. 17, 2010, which is a continuation of U.S.patent application Ser. No. 11/614,949, filed on Dec. 21, 2006, now U.S.Pat. No. 7,708,768, which is a continuation of U.S. patent applicationSer. No. 11/408,668, filed on Apr. 21, 2006, now U.S. Pat. No.7,594,925, which claims the benefit of priority under 35 U.S.C §119(e)to U.S. Provisional Patent Application No. 60/673,876, filed on Apr. 21,2005, the entireties of each of which are incorporated herein byreference.

BACKGROUND

Systems and devices exist for tracking a probe such as a catheter orendoscope through the body of a patient. Such systems and devices aredescribed in U.S. Pat. No. 6,188,355 entitled Wirelesssix-degree-of-freedom locator; U.S. Pat. No. 6,226,543 entitled Systemand method of recording and displaying in context of an image a locationof at least one point-of-interest in a body during an intra-body medicalprocedure; U.S. Pat. No. 6,380,732 entitled Six-degree of freedomtracking system having a passive transponder on the object beingtracked; U.S. Pat. No. 6,558,333 entitled System and method of recordingand displaying in context of an image a location of at least onepoint-of-interest in a body during an intra-body medical procedure; U.S.Pat. No. 6,574,498 entitled Linking of an intra-body tracking system toexternal reference coordinates; U.S. Pat. No. 6,593,884 entitledIntrabody navigation system for medical applications; U.S. Pat. No.6,615,155 entitled Object tracking using a single sensor or a pair ofsensors; U.S. Pat. No. 6,702,780 entitled Steering configuration forcatheter with rigid distal device; U.S. Pat. No. 6,711,429 entitledSystem and method for determining the location of a catheter during anintra-body medical procedure; U.S. Pat. No. 6,833,814 entitled Intrabodynavigation system for medical applications; and U.S. Pat. No. 6,996,430entitled Method and system for displaying cross-sectional images of abody. Each of which is incorporated by reference in their entirety.

In accordance with tracking devices as described above, novel medicalprocedures may require improved operator interface, beyond justpositioning, to improve treatment results or outcome. The treatment ofasthma is one such procedure. Devices and methods for treating airwaywalls are described in U.S. patent application Ser. No. 09/095,323titled METHOD AND APPARATUS FOR TREATING SMOOTH MUSCLES IN THE WALLS OFBODY CONDUITS filed Jun. 10, 1998; Ser. No. 10/414,253 titledMODIFICATION OF AIRWAYS BY APPLICATION OF ENERGY filed Apr. 14, 2003;Ser. No. 09/436,455 titled DEVICES FOR MODIFICATION OF AIRWAYS BYTRANSFER OF ENERGY filed Nov. 8, 1999; Ser. No. 09/999,851 titled METHODFOR TREATING AN ASTHMA ATTACK filed Oct. 25, 2001; Ser. No. 10/810,276titled METHOD OF TREATING AIRWAYS IN THE LUNG filed Mar. 26, 2004; Ser.No. 10/640,967 titled METHODS OF TREATING ASTHMA filed Aug. 13, 2003;Ser. No. 10/809,991 titled METHODS OF TREATING REVERSIBLE OBSTRUCTIVEPULMONARY DISEASE filed Mar. 26, 2004; and Ser. No. 10/954,895 titledINACTIVATION OF SMOOTH MUSCLE TISSUE filed Sep. 30, 2004; and U.S. Pat.No. 6,411,852 titled CONTROL SYSTEM AND PROCESS FOR APPLICATION OFENERGY TO AIRWAY WALLS AND OTHER MEDIUMS; and U.S. Pat. No. 6,634,363titled DEVICES FOR MODIFICATION OF AIRWAYS BY TRANSFER OF ENERGY. Alongwith U.S. Provisional Application Ser. Nos. 60/650,368 filed Feb. 4,2005; 60/625,256 filed Nov. 5, 2004; and 60/627,662 filed Nov. 12, 2004.Each of the above patent applications, patents and provisionalapplications are incorporated by reference herein in their entirety.

Various obstructive airway diseases have some reversible component.Examples include COPD and asthma. Asthma is a disease in whichbronchoconstriction excessive mucus production and inflammation andswelling of airways occur, causing widespread but variable airflowobstruction thereby making it difficult for the asthma sufferer tobreathe. Asthma is a chronic disorder, primarily characterized bypersistent airway inflammation. Asthma is further characterized by acuteepisodes of additional airway narrowing via contraction ofhyper-responsive airway smooth muscle.

In susceptible individuals, asthma symptoms include recurrent episodesof shortness of breath (dyspnea), wheezing, chest tightness and cough.Currently, asthma is managed by a combination of stimulus avoidance andpharmacology. Stimulus avoidance is accomplished via systemicidentification and minimization of contact with each type of stimuli. Itmay, however, be impractical and not always helpful to avoid allpotential stimuli.

Pharmacological management of asthma includes long term control throughthe use of anti-inflammatories and long-acting bronchiodilators. Shortterm pharmacological management of acute exacerbations may be achievedwith use of short-acting bronchiodilators. Both of these approachesrequire repeated and regular use of prescribed drugs. High doses ofcorticosteroid anti-inflammatory drugs can have serious side effectsthat require careful management. In addition, some patients areresistant to steroid treatment. The difficulty involved in patientcompliance with pharmacologic management and the difficulty of avoidingstimulus that trigger asthma are common barriers to successfulconventional asthma management. Accordingly, it would be desirable toprovide a management system and method that does not require regularpatient compliance.

Various energy delivering systems have been developed to intraluminallytreat anatomical structures by the controlled application of energy tointraluminal surfaces. Such systems may be specifically configured todeliver energy to lung tissue because of the clinical demands caused bythe heterogeneous nature of lung tissue, and specifically, variations inlung tissue lumen size due to the branching pattern of thetracheobronchial tree, variations in the vasculature of the lungs andvariations in the type of tissue in the lungs, including cartilage,airway smooth muscle, and mucus glands and ducts. Accordingly, a systemdesigned to delivery energy, and in some particular cases, radiofrequency energy, to lung tissue must take these variations into accountand deliver energy in a controlled manner.

Medical procedures involving the controlled delivery of therapeuticenergy to patient tissue are often demanding and may require a physicianto perform several tasks at the same time. In addition, medicalprocedures or other procedures may require specific energy deliveryparameters. As such, what has been needed is an energy delivery systemwith a user friendly control system that regulates and controls thedelivery of energy, prevents operation or energy delivery if a fault inthe energy delivery system is detected by the control system andprovides the user with information delivered in an easy to understandformat so that the information can be readily analyzed during ademanding medical procedure.

In addition, there remains a need to combine the treatment systemsdescribed herein with a mapping system that to eventually enable theuser to rely on safety measures as well as algorithms to enhance theprocedure.

SUMMARY

It is noted that while the following disclosure discusses the treatmentof asthma and the airways as one variation of the invention, theinvention is not limited to such an indication. The invention may beapplicable to nearly any medical treatment or therapy in which theassociation of information with treatment sites is useful.

In one embodiment of the invention, the invention includes a method fortreating a network of organs, such as the airways which have smoothmuscle tissue surrounding the airway luminal passageway, the methodcomprising, generating a map of at least a portion of the network oforgans using a rendering system; selecting at least one treatmentlocation within the luminal passageway of the network of organs; andapplying an energy therapy to the treatment location to treat the smoothmuscle tissue, where the energy therapy applied to the respectivetreatment location is defined by a plurality of parameters. Theseparameters may include but are not limited to time of treatment, timebetween treatments, temperature, energy, rate of change in temperature,rate of change in energy, impedance of the treatment location, and acombination thereof. The parameters may be displayed during orsubsequent to the treatment.

The term luminal passageway may include the cavity of a tubular or otherorgan such as the airways, esophagus, gastro-intestinal tract,vasculature, heart, kidneys, liver, bladder, and/or brain.

The map may be a virtual map or compiled map that is generated by acomputer aided tomography (CT), magnetic resonance imaging (MRI),positron emission tomography (PET), ultrasonic imaging, or other similarrendering system in which the desired anatomy may be essentially mappedthrough the compilation of various images or data. It should be notedthat the map or virtual map may simply be a graphical representation ofthe movement of the device within the body relative to a particularreference point. The map may also be purely a series of coordinatesrelative to a fixed reference point somewhere in the body. Such a map isuseful to identify the location of a device in the organs even thoughthe map is not represented in a graphic image.

Once the map is generated, it may be useful to orient the constructedmap with anatomical features or locations within the body. Suchorientation permits correlation of positions on the map with actualmovement of the device within the body. The map may be generated priorto beginning the actual treatment. For example, a patient may undergo aCT scan to generate the images necessary for construction of the map.Once completed, the medical procedure may be initiated with a completeor substantially complete map.

Although it may be useful to display the map on a visual display, suchas the visual display of an image provided by a scope-type device, themap may be displayed on a separate monitor apart from the visualdisplay. The monitor may provide a graphical illustration orrepresentation of the network of organs and/or may merely providepositioning data.

As noted above, the invention may combine some type of locating systemand locating implement to track the position of the device within thenetwork of organs (where the term device includes catheters, accessdevices, probes, or other such items). In one example, the locatingimplement and locating system described in the patents referenced abovemay be incorporated in the treatment device or in a separate device.However, variations of the invention may use other locating systems suchas RFID systems. In any case, the locating implement will communicatewith the locating system to establish a virtual position of the deviceon the map. Accordingly, the virtual position may then be imposed on thereal time image of the luminal passageways on a visual display.

The system of the present invention may also generate a treatmenthistory profile where the treatment history profile includes the virtualposition of the device at each treatment location when applying theenergy therapy. It should be noted that the treatment may be applied inone step (such as exposing the body to a single source of energy (fromwithin or outside the body.) Alternatively, sections of the organ may betreated with in stages (for example, when the organ is treated in stagesto alleviate the healing load on the organ, to minimize the patient'stime under sedation, etc.).

Control System

With regards to the control system, in one embodiment, a system fordelivering activation energy to a therapeutic energy delivery devicehaving a temperature detecting element and an energy emission elementincludes an energy generator configured to be coupled to the energyemission element. The energy generator has an activation state and astandby state, where activation energy is delivered to the energyemission device in the activation state and not in the standby state. Acontroller having a processor and a user interface surface with a visualindicator is coupled to the energy generator and the processor isconfigured to activate the visual indicator when a temperature measuredby the temperature detecting element is not within a pre-determinedtemperature range.

In another embodiment, an energy delivery system includes a therapeuticenergy delivery device having a distal portion configured to bedelivered to a treatment site. The distal portion includes a temperaturedetecting element and an energy emission element. An energy generator isconfigured to be coupled to the energy emission element and has anactivation state and a standby state, where activation energy isdelivered to the energy emission element in the activation state and notin the standby state. A controller having a processor and a userinterface surface with a visual indicator is configured to activate thevisual indicator when a temperature measured by the temperaturedetecting element is not within a pre-determined temperature range.

In another embodiment, a system for delivering activation energy to atherapeutic energy delivery device having a temperature detectingelement and an energy emission element includes an energy generatorconfigured to be coupled to the energy emission element. The energygenerator has an activation state and a standby state, where activationenergy is delivered to the energy emission device in the activationstate and not in the standby state. A controller having a processor anda user interface surface with a visual indicator is configured toactivate the visual indicator when an impedance of an energy emissioncircuit between the energy generator, the energy emission element and apatient is not within a pre-determined impedance range.

In another embodiment, an energy delivery system includes a therapeuticenergy delivery device having a temperature detecting element and anenergy emission element. An energy generator is configured to be coupledto the energy emission element and has an activation state and a standbystate, where activation energy is delivered to the energy emissionelement in the activation state and not in the standby state. Acontroller having a processor and a user interface surface with a visualindicator is configured to activate the visual indicator when animpedance of an energy emission circuit between the energy generator,the energy emission element and a patient is not within a pre-determinedimpedance range.

In yet another embodiment, a system for delivering activation energy toa therapeutic energy delivery device having a temperature detectingelement and an energy emission element includes an energy generatorconfigured to be coupled to the energy emission element. The energygenerator has an activation state and a standby state, where activationenergy is delivered to the energy emission device in the activationstate and not in the standby state. A controller having a processor anda user interface surface with a first visual indicator and a secondvisual indicator, is configured to activate the first visual indicatorwhen a temperature measured by the temperature detecting element is notwithin a pre-determined temperature range and to activate the secondvisual indicator when an impedance of an energy emission circuit betweenthe energy generator, the energy emission element and a patient is notwithin a pre-determined impedance range.

In another embodiment, an energy delivery system includes a therapeuticenergy delivery device configured to be delivered to a treatment site.The energy delivery device has a temperature detecting element and anenergy emission element. An energy generator is configured to be coupledto the energy emission element and has an activation state and a standbystate, where activation energy is delivered to the energy emissionelement in the activation state and not in the standby state. Acontroller having a processor and a user interface surface with a firstvisual indicator and a second visual indicator is configured to activatethe first visual indicator when a temperature measured by thetemperature detecting element is not within a pre-determined temperaturerange and to activate the second visual indicator when an impedance ofan energy emission circuit between the energy generator, the energyemission element and a patient is not within a pre-determined impedancerange.

In another embodiment, an energy delivery system includes a therapeuticenergy delivery catheter having an electrode and temperature detectingelement disposed on a distal portion of the catheter. The distal portionof the catheter is configured to be delivered to a treatment siteadjacent target tissue of a patient and deliver a treatment cycle oftherapeutic RF energy to the target tissue. An RF energy generator isconfigured to be coupled to the electrode and has an activation stateand a standby state, where RF energy is delivered to and emitted fromthe electrode in the activation state and not in the standby state. Acontroller having a processor and a user interface surface with a firstvisual indicator and second visual indicator is configured to processtemperature measurements taken by the temperature detecting element andimpedance measurements between the RF energy generator and the targettissue prior to activation of the RF energy generator to the activationstate. The processor is also configured to activate the first visualindicator if a temperature measured by the temperature detecting elementis not within a pre-determined temperature range and activate the secondvisual indicator when an impedance between the RF energy generator andtarget tissue adjacent the electrode is above a predetermined value.

These features of embodiments will become more apparent from thefollowing detailed description when taken in conjunction with theaccompanying, exemplary drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of a system for delivering energy to the walltissue of a patient's lung.

FIG. 2 is an enlarged view of a distal portion of a therapeutic energydelivery device.

FIG. 3 is an enlarged view of the encircled portion 3 in FIG. 2illustrating a more detailed view of an energy emission element andtemperature detecting element of the therapeutic energy delivery device.

FIG. 4 is an elevational view of a user interface surface of acontroller.

FIGS. 5A and 5B are flow diagrams depicting various processes androutines that control the user interface surface elements.

FIG. 6A is a schematic view of a system for delivering energy to thewall tissue of a patient's lung along with the visual and virtualdisplays.

FIG. 6B is a representation of a rendering system for generating a map.

FIG. 6C is a schematic view of a system for delivering energy to thewall tissue of a patient's lung when the device is advanced within thelungs and imaged on the visual and virtual displays.

FIG. 6D is an enlarged view of a distal portion of a therapeutic energydelivery device along with elements that enable the mapping of thedevice within the body.

FIG. 6E is a sample view of a virtual map showing the virtual positionof the device along with various information to assist the medicalpractitioner in carrying out the treatment.

DETAILED DESCRIPTION

Embodiments of systems and methods for delivering energy to tissue of apatient in a controlled manner are discussed, and specifically, systemsand methods for controlled delivery of radiofrequency (RF) energy tolung tissue, bronchial tissue or both. However, the present systems andmethod may include various other types of energy delivery modes thatachieve the intended treatment of tissue. During the procedure, themedical practitioner applies therapy to the treatment locations wherethe energy applied to the respective treatment location is defined by anumber of parameters. Recordation of these parameters and association ofthe parameters with the treatment site may be important for a number ofreasons, including follow-up evaluation, further treatment, or to avoidexcessive treating of an area.

Embodiments of the systems and methods may be configured to consolidateand effectively communicate relevant information to a user of thesystems, including detecting accessory (e.g. therapeutic device,footswitch, electrode return pad, or other) connections and serving asan automatic trouble shooting guide with user friendly instructions,information, indicators and the like.

FIG. 1 shows a schematic diagram of a system for delivering therapeuticenergy 10 to tissue of a patient having an RF energy generator 12, acontroller 14 coupled to the energy generator, a user interface surface16 in communication with the controller 14 and a therapeutic energydelivery device, in the form of an RF energy delivery device 18, coupledto an interface coupler 20 on the user interface surface 16. Thecontroller 14, which is coupled to the energy generator 12 and userinterface surface 16, is configured to control the energy output of theenergy generator 12. The user interface surface 16 may include switches,a digital display, visual indicators, graphical representations ofcomponents of the system and an audio tone generator as well as otherfeatures. The controller 14 includes a processor 22 that is generallyconfigured to accept information from the system and system components,and process the information according to various algorithms to producecontrol signals for controlling the energy generator 12. The processor22 may also accept information from the system 10 and system components,process the information according to various algorithms and produceinformation signals that may be directed to the visual indicators,digital display or audio tone generator of the user interface in orderto inform the user of the system status, component status, procedurestatus or any other useful information that is being monitored by thesystem. The processor 22 of the controller 14 may be digital ICprocessor, analog processor or any other suitable logic or controlsystem that carries out the control algorithms. Some of the controlalerts, information, feedback and testing routines are shown in the flowdiagram of FIGS. 5A and 5B.

The system 10 also includes an electrode return pad 24 and a footswitch26, both of which are coupled to respective interface couplers 28 and 30on the user interface surface 16. The user interface surface 16 alsoincludes a digital display 32 that may be used to display numeric datato a user of the system 10. The arrangement of the user interfacesurface 16 provides a user friendly interface for the system 10 thatprovides feedback and system information to a user in an intuitivedisplay format. System components that couple to the user interfacesurface 16, such as the footswitch 26, electrode return conductive pad24 and energy delivery device 18, couple to the user interface surface16 adjacent graphical representations of the respective systemcomponents. In addition, visual indicators that are configured todisplay information about these various system components may also bedisposed adjacent or within the respective graphical representation ofeach system component. This configuration allows a user to easily andintuitively couple system components to the proper interface on the userinterface surface 16 and also allows a user to easily and intuitivelycorrelate audio and visual system feedback to the appropriate systemcomponent.

Referring again to FIG. 1, the energy delivery device 18 includes anelongate shaft 34, a handle 36 secured to a proximal end of the elongateshaft 34 and a control cable 38 that extends from the handle 36 to aproximal coupler 40 that is configured to couple to the interfacecoupler 20 on the user interface surface 16. A sliding switch 42 on thehandle 36 controls the radial expansion and contraction of a distalelectrode basket 44 disposed on a distal end of the elongate shaft 34.The elongate shaft 34 may have a variety of configurations, includingstiff, flexible, steerable with distal tip deflection and the like. Theelongate shaft 34 and distal portion may also be configured and sized topermit passage of the elongate shaft 34 through the working lumen of acommercially available bronchoscope. In addition, the controller 14 mayalso include an optional interface coupler (not shown) that isconfigured to couple to a bronchoscope camera trigger such that when theprocessor 22 of the controller 14 initiates a treatment cycle byswitching the RF energy generator from a standby state to an activationstate, a triggering signal is also generated by the controller toinitiate video taping or displaying of an image produced by thebronchoscope camera which is coupled to a bronchoscope being used toposition the energy delivery device 18 during a procedure or treatmentcycle. Alternatively, the controller may utilize the interface couplerto send some or all of the controller output to the bronchoscope videoprocessor or monitor. In this way, the information displayed on thecontroller's user interface surface can also be displayed on any of thedisplays associated with the bronchoscope. Additionally, controlleroutput information that is not displayed on the controller's userinterface surface can be displayed on any of the displays associatedwith the bronchoscope. This may be of use, because the physician istypically focused on the bronchoscope display when conducting aprocedure.

The distal electrode basket 44 may be seen in more detail in FIGS. 2 and3. The distal electrode basket 44 is a flexible and resilient ovalshaped basket that includes an energy emission element in the form of anelectrode 46 that is formed from an exposed section of a basket leg 48which is nominally coated with an electrical insulator material 50 inthe areas outside of the exposed section. The distal electrode basket 44also includes a temperature detection element in the form of athermocouple 52 disposed on or adjacent the electrode 46. Thethermocouple 52 has leads 54 and thermocouple termination points 56which are secured to the exposed section 58 of the basket leg orelectrode 46.

The leads 54 of the thermocouple 52 and a conductor (not shown) inelectrical communication with the electrode 46 extend proximally fromthe distal basket 44 to the handle 36 and then proximally through thecontrol cable 38 to the proximal coupler 40. This configuration allowsthe electrode 46 and the thermocouple leads 54 to be electricallycoupled in a modular arrangement with the controller 14 through the userinterface surface 16. The interface coupler 20 configured to accept theproximal coupler 40 of the energy delivery device 18 is disposedadjacent a graphical representation 60 of an embodiment of the energydelivery device 18 which is printed on the user interface surface 16.This provides a useful visual prompt for a user who is setting up thesystem 10. Once the proximal coupler 40 is connected to the interfacecoupler 20 for the energy delivery device 18, the electrode 46 is now inelectrical communication with the RF energy generator 12, subject tocontrol and modulation by the controller 14 which may switch the RFgenerator 12 back and forth between an active state and a standby state,during which no RF can be delivered. In addition, the leads 54 of thethermocouple 52 are also in electrical communication with the controller14 so that the controller 14 may monitor the temperature of the tissueadjacent the electrode 46. In this arrangement, the RF energy generator12, controller 14 and user interface 16 form a system for controlleddelivery of activation energy to the energy delivery device 18.

The electrode 46 may be monopolar or bipolar, however, if the electrode46 is a monopolar electrode, a return electrode component 62 may be usedwith the system 10 in order to complete an electrical energy emission orpatient circuit between the RF energy generator 12 and a patient (notshown). The electrode return 62 includes the conductive pad 24, aproximal coupler 64 and a conductive cable 66 extending between and inelectrical communication with the conductive pad 24 and proximal coupler64. The conductive pad 24 may have a conductive adhesive surfaceconfigured to removably stick to the skin of a patient and with a largeenough surface area such that no burning or other injury to thepatient's skin will occur in the vicinity of the conductive pad 24 whilethe system 10 is in use. The proximal coupler 64 is configured to coupleto the interface coupler 28 on the user interface surface 16. Theinterface coupler 28 for the electrode return 62 is disposed adjacent agraphical representation 68 of the electrode return 62 on the userinterface surface 16. Once again, this provides a useful visual promptfor a user who is setting up the system 10.

Once the proximal coupler 40 of the energy delivery device 18 and theproximal coupler 64 of the electrode return 62 have been coupled to thecontroller 14 via the respective interface couplers 20 and 28 of theuser interface surface 16, RF energy may be generated by the RFgenerator 12, i.e., the RF generator 12 is switched to an activationstate, and emitted from the electrode 46 of the distal basket 44 of theenergy delivery device 18 into target tissue of the patient adjacent theelectrode 46. The processor 22 may then adjust the output of the RFgenerator 12 in order to maintain a substantially constant temperatureof tissue adjacent the electrode via a feedback loop between thethermocouple 52 and the processor 22. The processor 22 may use a controlalgorithm to process the temperature feedback and generate controlsignals for the RF generator 12. In addition, control algorithm may beconfigured to set predetermined dwell or activation times forembodiments of treatment cycles. Embodiments of control algorithms andsystem components that may be used in conjunction with control deviceand method embodiments discussed herein may be found in U.S. patentapplication Ser. No. 10/414,411, titled “Control System and Process forApplication of Energy to Airway Walls and Other Mediums”, filed Apr. 14,2003, which is incorporated by reference herein in its entirety.

In one embodiment, the RF generator 12 generates RF energy at afrequency of about 400 kHz to about 500 kHz in with a wattage outputsufficient to maintain a target tissue temperature of about 60 degreesC. to about 80 degrees C., specifically, about 60 degrees C. to about 70degrees C. The duration of the activation state for an embodiment of asingle treatment cycle may be about 5 seconds to about 15 seconds,specifically, about 8 seconds to about 12 seconds. Alternatively, theduration of the activation state of the RF generator may also be set tonot more than the duration required to deliver about 150 Joules ofenergy to the target tissue, specifically, not more than the durationrequired to deliver about 125 Joules of RF energy to target tissue.

The initiation of the activation state of the RF generator 12 may becarried out by a variety of devices and methods, however, the embodimentof FIG. 1 includes a user operated activation switch in the form thefootswitch 26. A conductive cable 70 is coupled to and disposed betweenthe footswitch 26 and a proximal coupler 72 which is configured to beelectrically coupled to the respective interface coupler 30 disposed onthe user interface surface 16. The interface coupler 30 for the proximalcoupler 72 of the footswitch 26 is disposed adjacent a graphicalrepresentation 74 of the footswitch 26 on the user interface surface 16.The footswitch 26 may be used in some configurations to initiate anactivation state of the RF energy generator 12 if all components of thesystem 10 are functioning and connected properly. This can be defined asthe controller entering into the ready mode

Referring now to FIG. 4, a more detailed view of an embodiment of theuser interface surface 16 is shown. The user interface surface 16 may bea substantially rectangular and flat surface as shown in FIG. 4, but mayalso have any other suitable shape, size or configuration. The userinterface surface 16 may, in some embodiments, be any part of an energydelivery system, or component thereof, that a user may access or see inorder to impart information or receive information therefrom. Thecontroller 14 may have an alternating current (AC) power on/off switchthat may be located anywhere on the controller 14, or alternatively, onthe user interface surface 16. However, for the embodiment shown in FIG.4, the user interface surface 16 does not include an AC power on/offswitch. The controller 14 or user interface surface 16 may include anaudio tone generator (not shown) which may be used in conjunction withthe various visual indicators of the system 10 to alert a user to thestatus of the various components of the system 10. In one embodiment,the audio tone generator includes a speaker (not shown) which may bemounted on any suitable surface of the controller 12 or the userinterface surface 16.

The user interface surface 16 has a visual indicator in the form of amulti-colored LED ready indicator light 76 in the upper left hand cornerof the user interface surface 16. The ready indicator light 76 may beactivated or lit with a first color, such as a green color, when the RFenergy generator 12 is ready for use in a standby state. The LEDindicator 76, may be activated and lit with a second color, such as anamber color, when the RF energy generator 12 is switched on into anactivation state at which time a brief audio tone may also sound uponthe transition of the RF generator 12 from the standby or ready state tothe activation state with RF energy being delivered to the energyemission element 46 of the energy delivery device 18. Additionally, aseparate LED indicator 92 may be activated and lit with a second color,such as a blue color, during RF energy delivery. Typically, a useractivates the RF energy generator 12 for a treatment cycle by depressingand releasing the footswitch 26. The color of the ready indicator light76 may be switched back to the first color if, during an activationcycle, the footswitch 26 of the system 10 is depressed and releasedagain so as to produce a footswitch shutoff response from the processor22 which switches the RF energy generator 12 from the activation stateto the standby state. The second color or amber color may also bedisplayed by the ready indicator light 76 when the system 10 is engagedin a power on self-test (POST) mode during which time the audio tonegenerator may be delivering a constant single pitch tone. In addition,the second amber color may also be displayed by the ready indicator whena fault with the energy delivery device 18, such as a broken electrode46 or broken thermocouple 52, is detected by the controller 14. Theactivation of the second color indicating a fault with the energydelivery device 18 may also be accompanied by an audible first errortone from the audio tone generator. The ready indicator light 76 mayflash the first color, green, when the system 10 is conducting a cyclingof the AC power to the controller 14 in order to reset the system 10during which time the audible first error tone may also be produced. Inessence, the ready indicator light 76 emits a first color when thesystem 10 is ready to use and a second color or amber color if thesystem 10 has detected a fault in the system 10 and is not ready to use.

Below the LED ready indicator 76 is the graphical representation 74 ofthe footswitch 26 which is printed on the user interface surface 16. Thegraphical representation 74 of the footswitch 26 is, directly above andadjacent to the interface coupler 30 which is configured to accept theproximal coupler 72 of the footswitch 26 assembly. The graphicalrepresentation 74 of the footswitch 26 adjacent the interface coupler 30for the footswitch 26 provides an intuitive and user friendly prompt forthe user to locate the plug in point for the footswitch 26 while settingup the system 10.

To the right of the graphical representation 74 of the footswitch 26 isthe graphical representation 68 of the electrode return assembly 62which includes the conductive pad 24, conductive cable 66 and proximalcoupler 64 and which is printed on the user interface surface 16. Thegraphical representation 78 of the proximal coupler 64 of the electrodereturn assembly 62 is disposed directly above and adjacent to theinterface coupler 28 for the proximal coupler 64 of the electrode returnassembly 62. A visual indicator in the form of an amber colored LEDlight 80 is disposed within the graphical representation 82 of theconductive pad 24 of the electrode return assembly 62 and on the userinterface surface 16. The visual indicator 80 may be configured to belighted in a steady state when the system 10 is proceeding through thePOST which may also be accompanied by a single pitch audible tone fromthe audio tone generator. The visual indicator 80 may also be activatedand lighted when the controller 14 measures an impedance in the patientcircuit that is above a predetermined value after 3 or more attempts toactivate the RF energy generator to the activation state. A second errortone may accompany the activation of the visual indicator in thiscircumstance. For some embodiments, the predetermined impedance valuefor the patient circuit may be above about 1000 Ohms, specifically,above about 900 Ohms. Such a high impedance measurement in the patientcircuit indicates an open circuit and requires that the user check thepatient circuit and try the system 10 another time. The patient circuitincludes the electrode 46 and conductive cable 38 of the energy deliverydevice 18, the patient (not shown) with the conductive pad 24 andelectrode 46 in electrical communication with the patient's body, andthe electrode return assembly 62, The visual indicator 80 may also beactivated or lighted in a flashing mode when a fault requiring the userto cycle AC power has been initiated by the processor 22, during whichtime a first audible error tone may also be generated by the audio tonegenerator.

To the right of the graphical representation 68 of the electrode return62, the graphical representation 60 of the energy delivery device 18 isprinted on the user interface surface 16 including the handle 36, theelongate shaft 34 and the distal electrode basket 44. The interfacecoupler 20 configured to accept the proximal coupler 40 of the energydelivery device 18 is disposed adjacent and directly below a graphicalrepresentation 84 of the handle 36 of the energy delivery device 18. Afirst visual indicator in the form of an amber LED light 86 is disposedwithin the graphical representation 88 of the distal electrode basket 44on the user interface surface 16. A second visual indicator 90, having asecond color different from the first visual indicator, in the form of ared LED light 90 is disposed within the graphical representation 84 ofthe handle 36.

The first visual indicator 86 may be activated and lighted for someembodiments of the system 10 when the controller 14 measures animpedance in the patient circuit that is above a predetermined value.For some embodiments, the predetermined impedance value for the patientcircuit may be above about 1000 Ohms, specifically, above about 900Ohms. A first audible error tone may also be generated during such anactivation. The first visual indicator 86 may also be lighted oractivated when the measured impedance of the patient circuit is abovesuch a predetermined value during at least 3 or more attempts toactivate the RF energy generator 12 to the activation state. In thiscircumstance, a second audible error tone may also be generated inconjunction with the activation of the first visual indicator 86. Thefirst visual indicator 86 may also be lighted in a steady state when theprocessor 22 of the system 10 is proceeding through the POST which mayalso be accompanied by a single pitch audible tone from the audio tonegenerator. The visual indicator 86 may also be activated or lighted in aflashing mode when a fault requiring the user to cycle AC power has beeninitiated by the processor 22, during which time a first audible errortone may also be generated by the audio tone generator.

The second visual indicator 90 may be activated or lighted in a flashingor intermittent mode when a fault with the energy delivery device 18,such as a broken electrode 46 or broken thermocouple 52, is detected bythe controller 14. The activation of the second visual indicator 90suggesting a fault with the energy delivery device 18 may also beaccompanied by an audible first error tone from the audio tonegenerator. The second visual indicator 90 may also be lighted in asteady state when the processor 22 of the system 10 is proceedingthrough the POST which may also be accompanied by a single pitch audibletone from the audio tone generator. The second visual indicator 90 mayalso be activated or lighted in a flashing mode when a fault requiringthe user to cycle AC power has been initiated by the processor 22,during which time a first audible error tone may also be generated bythe audio tone generator.

Another visual indicator 92 in the form of a graphical representation ofa radiating electrode is disposed on the user interface surface 16. ThisRF energy indicator 92, which may be a third color or blue LED, isactivated or lighted in a flashing mode during the time when the RFenergy generator 12 is switched to the activation state and deliveringRF energy to the energy delivery device 18. The RF energy indicator 92may also be lighted in a steady state when the processor 22 of thesystem 10 is proceeding through the POST which may also be accompaniedby a single pitch audible tone from the audio tone generator. The RFenergy indicator 92 may also be activated or lighted in a flashing modewhen a fault requiring the user to cycle AC power has been initiated bythe processor 22, during which time a first audible error tone may alsobe generated by the audio tone generator.

A digital display 94 is disposed on the user interface surface 16 belowthe RF energy indicator 92 and is configured to display numericalinformation. The digital display 94 may be controlled or otherwise resetby a switch 96 disposed directly below the digital display 94 on theuser interface surface 16. In a normal mode, the digital display 94 willdisplay the number of successful treatment cycles delivered by thesystem 10 performed by a user of the system 10. If the switch 96 isdepressed for less than about 2 seconds to about 4 seconds, the numberof unsuccessful or incomplete treatment cycles is displayed for a briefperiod, such as about 5 seconds. After this brief period, the digitaldisplay 94 reverts back to a display of the number of completedtreatment cycles. When the switch 96 is depressed and held for more thana brief period of about 2 seconds to about 4 seconds, the digitaldisplay 94 shows a “0” for a short period, such as about 1 second. Ifthe switch 96 is held depressed during this short 1 second period, thecount of the complete and incomplete treatment cycles is reset to 0. Ifthe switch 96 is released during this short 1 second period, the digitaldisplay 94 reverts back to a display of the completed or successfultreatment cycles without resetting the treatment cycle counter.

Referring to FIGS. 5A and 5B, a variety of system process embodimentsare shown in flow diagram form. In use, the system 10 for delivery oftherapeutic energy is first supplied with power, such as AC power, whichmay be carried out by a switch (not shown) on the controller 14 or userinterface surface 16, as discussed above. Once AC power is supplied tothe controller 14, the user initiates the POST cycle, indicated by box100, which tests the integrity of the processor 22, the controller 14and the system 10 generally. If the POST fails, the processor 22initiates a cycling of the AC power in order to reboot the controller14, and specifically, the processor 22 of the controller 14. Inaddition, once AC power has been supplied to the controller 14, theprocessor 22 continually runs a first background algorithm, indicated bythe decision point “irrecoverable error” 102. The irrecoverable errortest checks for hardware and processor errors such as CPU configuration,COP timeout, ROM CRC error, RAM, illegal CPU instruction, software,non-volatile memory, RF current measurement errors. If such an error isdetected, the user should initiate a cycling of the AC power, asindicated by box 111, in order to reboot the controller 14, andspecifically, the processor 22 of the controller 14. During the cyclingof the AC power, the user will be informed of the cycling status by aflashing of all visual indicators on the user interface surface 16 aswell as a flashing of the digital display 94 and the concurrentgeneration of an audible error tone.

If the POST is successful, the processor 22 will initiate a testalgorithm that determines whether all connections of system components,such as the energy delivery device 18, return electrode 62 andfootswitch 26 are all properly coupled to the respective interfacecouplers 20, 28 and 30 of the user interface surface 16, as indicated bydecision point 104. If an error is detected during this routine, theready indicator light 76 will remain in the second or amber color state,indicating that the RF energy generator 12 is not ready or in thestandby state. Once the system components such as the energy deliverydevice 18, electrode return 62 and footswitch 26 are properly coupled tothe user interface 16, the processor 22 will initiate an algorithm thatdetermines whether the temperature detection element, or thermocouple52, of the energy delivery device 18 is properly functioning asindicated by box 106.

During this test, the processor 22 measures the temperature indicated bythe thermocouple 52 and compares the result to a predeterminedtemperature range, that encompasses room temperature for someembodiments. For example, the predetermined temperature range for someembodiments may be about 15 degrees C. to about 35 degrees C.,specifically, about 20 degrees C. to about 30 degrees C. If the measuredtemperature indicated by the thermocouple 52 does not fall within thepredetermined temperature range, the processor 22 indicates a brokenthermocouple 52 by initiating an error message to the user whichincludes switching the ready indicator light 76 to the second or ambercolor in addition to initiating a flashing mode activation of the redLED second visual indicator 90 in the handle 84 of the graphicalrepresentation 60 of the energy delivery device 18. An audible errortone may also accompany the error message generated by the visualindicators 76 and 90. These error messages inform the user that it maybe necessary to replace the energy delivery device 18 with a new one.

Once the thermocouple test has been successfully performed, theprocessor 22 will switch the ready indicator light 76 to the first coloror green color indicating that the system 10 is now ready to perform atreatment cycle in a patient, as indicated by box 108. At this point,the user may then position the distal electrode basket 44 of the energydelivery device 18 such that at least one emission element or electrode46 is disposed adjacent target tissue of the patient, such as smoothmuscle of the patient's bronchial airways. Once the electrode 46 isproperly positioned, the user depresses the footswitch 26 to initiate atreatment cycle, as indicated by user action/input box 110. Upondepression of the footswitch 26, the processor 22 immediately measuresthe impedance of the patient circuit, and if the impedance is below apredetermined maximum or within a predetermined impedance range, theprocessor 22 switches the RF energy generator 12 from the ready orstandby state to the activation state wherein RF energy is beingdelivered to the target tissue of the patient for the initiation of atreatment cycle.

For some embodiments of a normal treatment cycle, as indicated by resultbox 112, the processor 22 and algorithms run by the processor 22 areconfigured to maintain the RF energy generator 12 in the activationstate for a dwell time of about 5 seconds to about 15 seconds,specifically, about 8 seconds to about 12 seconds. The duration of thetreatment cycle may also be constrained by the total energy delivered tothe target tissue during the cycle. For example, the processor 22 mayexecute an algorithm which terminates the treatment cycle when the totalenergy delivered to the target tissue is up to about 150 Joules,specifically, up to about 125 Joules. During the treatment cycle, theprocessor 22 controls the output of the RF energy generator 12 in orderto maintain a substantially constant temperature of the target tissue.The temperature of the target tissue during a treatment cycle embodimentmay be maintained at a temperature of about 60 degrees C. to about 80degrees C., specifically, from about 60 degrees C. to about 70 degreesC. As discussed above, the processor 22 is able to maintain thesubstantially constant temperature of the target tissue by monitoringthe temperature of the target tissue via the temperature measuringelement or thermocouple 52 and processing the temperature information ina feedback loop with lowers the RF energy generator 12 output if themeasured temperature is higher than desired and increasing the RF energygenerator output if the measured temperature is lower than desired.

During the treatment cycle, the processor 22 will switch the blue RFenergy visual indicator 92 to an activated solid, or flashing mode andwill activate the audio signal generator to generate a dual pitchaudible tone from the audible tone generator that repeats a high pitchthen low pitch audible tone during the treatment cycle, followed by along single pitch tone at the end of a successful cycle. If an erroroccurs in the middle of a treatment cycle, an audible error tone will begenerated and the visual indicator or indicators indicative of the errorwill be activated as discussed above. As discussed above, a treatmentcycle may also be interrupted by the user's depression of the footswitch26 during the treatment cycle to initiate a footswitch shutoff, asindicated by user action box 114. This may be done if the user feelsthat the system 10 is operating improperly for any reason, the userfeels that the location of the electrode 46 is wrong, or for any otherreason. A footswitch shutoff action by the user returns the system 10 tothe RF generator ready state, indicated by box 108, but does not log acompleted or successful treatment cycle on the digital display 94. Ifthe treatment cycle is successfully completed, the digital display 94will display a count of “1” indicating one successfully completedtreatment cycle.

If an error occurs during the treatment cycle, as indicated by resultbox 116, or the footswitch shutoff option is used, a “0” will remaindisplayed. However, if the display control switch 96 is depressed formore than about 2 seconds to about 4 seconds, the digital display 94will show a “1”, indicating one incomplete or unsuccessful treatmentcycle. The user may continue to deploy the energy delivery device 18 tonew locations within the patient's anatomy and activate the RF energygenerator 12 to the activation state for any desired number of treatmentcycles. If an error occurs during a treatment cycle, as indicated byresult box 116, the user interface 16 will then display via theappropriate visual indicators and audible tone indicators, the type oferror that has occurred and will recommend a course of action for theuser. After correction has been attempted by the user, the footswitch 26may again be depressed, as indicated by user action/input box 118, inorder to initiate another treatment cycle.

If the impedance of the patient circuit is greater than a predeterminedmaximum or not within a predetermined impedance range upon depression ofthe footswitch 26, as indicated by result box 120, one of two errormessages including visual indicators and audible tones may be generatedby the system 10. Specifically, if a high impedance is measured upon afirst depression of the footswitch 26 or a second depression of thefootswitch 26, as indicated by box 122, the error message “improvedeployment and continue” will be generated, as discussed above, wherebythe amber visual indicator 86 of the distal basket graphic 88 on theuser interface 16 will be activated and lighted and a first error tonewill be generated by the audible tone generator. In addition, anincomplete treatment cycle will be logged by the digital display 94.Once attempted correction has been made, the footswitch 26 may again bedepressed as indicated by user action/input box 124, in which case thetreatment cycle is reinitiated.

If on the third or subsequent depression of the footswitch 26 the sameerror is detected by the system 10, the “check patient circuit” errormessage will be generated, as discussed above, whereby the amber visualindicator 80 of the return electrode graphic 82 and the amber visualindicator 86 of the electrode basket graphic 88 on the user interfacesurface 16 will be activated and lighted. Such an error message may alsobe accompanied by a second audible error tone generated by the audibletone generator. In addition, an incomplete treatment cycle will belogged by the digital display 94. After attempted correction of theerror, the footswitch 26 may again be depressed, as indicated by useraction/input box 126, in order to initiate another treatment cycle.

FIG. 6A shows a system schematic diagram of a system 10 as describedherein. The system may have any number of visual displays 130 fordisplaying treatment information, treatment parameters, virtual maps,positioning, or other, data useful to the medical practitioner. Forexample, many endoscopic procedures include at least one visual display.130 that shows a real-time picture of the target site (and in some casesthe tip of the treatment device 18). A map may be projected onto aseparate monitor for the virtual display 132 as shown.

The virtual display 132 may comprise an entire virtual map, a virtualtreatment location, or a virtual location of the device. Alternatively,the two displays 130 and 132 may be combined so that a virtual displayis superimposed onto a visual display or disposed along side of thevisual display. However, the map may be also be shown in numerical form(e.g., such as a display of positioning information 131) on eitherdisplay 130 or 132. It should be noted that the visual display 130 maybe any type associated with endoscopic devices (in the case of thelungs—bronchoscopic devices). Furthermore, the visual display may bealternative real-time visual displays (e.g., fluoroscopic or othernon-invasive real time imaging means). In another variation of thedevice, a map may be incorporated into the user interface 16 of thecontroller 14.

The systems and methods described herein include generating a map of atleast a portion of the organ or network of organs (in this case thelungs 2) being mapped using a rendering system as shown in FIG. 6B.Generation of the map may include using a rendering system 128 thatincludes a computer aided tomography (CT), magnetic resonance imaging(MRI), positron emission tomography (PET), ultrasonic imaging, or othersimilar rendering system. The rendering system may produce agraphical/virtual map or a map that is purely a series of coordinatesrelative to a fixed reference point somewhere in the body.

For example, as shown in FIG. 6B, the rendering system 128 may be asystem that is external to the body (such as a CT, MRI, PET, etc.).Alternatively, the rendering system may have a probe or other component129, where the tracking system generates data or coordinates of theprobe/device (ultimately the data may be recorded on some storagedevice) as it travels through the organ. In such a case, until the mapdata is presented in a virtual map on a display, the map consists ofdata only. Such a map will be used in systems not having a graphicdisplay such as the one shown in FIG. 1. Instead, these data-only mapsmay be integrated with the user interface 16, generator 12, orcontroller 14 to provide a simple signal (audible, visual, or other)during a treatment session to indicate whether the operator has, forexample, already treated in the particular area.

The displays 130 and 132 may also be used to provide various information131 (such as treatment parameters, whether a treatment was previouslyapplied to the location, etc.). Furthermore, the information 131displayed may also include information from the user interface 16 (asdiscussed below) thereby eliminating the need for the medicalpractitioner to constantly shift focus from the user interface 16 to thedisplays 130 or 132. Although FIG. 6A shows the visual display connectedto a generator and controller, any number of configurations is possible.Those shown are for illustrative purposes only.

The map may be rendered/constructed prior to treating the patient or maybe rendered as the patient is treated. For example, CT equipment may notbe available in the same operating suite as the treatment device.Accordingly, the medical practitioner may use the rendering system togenerate the map for use with a later scheduled procedure.

In one variation of the invention, as shown in FIG. 6C, once the map isrendered it is oriented with one or more locations in the network oforgans. This orientation correlates the map data with actual physicalsites. One way of orienting the map, is to advance the device 18 intothe lung to a known location (e.g., the first bifurcation of the mainstem bronchus 142). Once the device 18 is in position, then the userwill use the locating system 138 to orient the virtual image of the site(as shown on FIG. 6A) with the actual site. This may be repeated forseveral sites.

As shown in FIG. 6C, the virtual image 136 shows a virtual map of theairways. As the device 18 advances into the organ, a locating implement(not shown) on the device 18 communicates with a locating system 138 toprovide a real position of the device. So long as the virtual mapcorrelates with the actual structure of the organ, an accurate virtualposition of the device 18 can be displayed on the virtual map. Asdiscussed herein, as the device 18 applies treatment in the lung 2, thetreatment parameters and/or location may be viewed by the medicalpractitioner on the system 10 or displays 130, 132.

FIG. 6D illustrates one example of a locating implement 140 coupled to adevice 18. The locating implement 140 communicates with the locatingsystem 138 to track the device 18 as it moves within the organ. Examplesof such locating implements and systems are found in the referencescited and incorporated by reference above.

Furthermore, the treatment system 10, the visual display 130, virtualdisplay 132, and/or locating system 138 may be coupled together suchthat treatment parameters are associated with their respective treatmentsites to generate a treatment history profile for the patient.Naturally, this information may be electronically recorded within thecontroller 14, locating system 138, or any other component of thesystem. This previous treatment history profile may be loaded for useduring a subsequent treatment session. It may be preferably to store thetreatment history profile electronically on a computer system or memoryof the controller or even on the rendering system that may be standalone or integrated in any of the components of the system.

The parameters may include time or duration of treatment, temperature(of the site, the device, or an adjacent site), energy, power, averagepower, status/incomplete activations, position of treatment, totalenergy applied, rate of change in temperature, rate of change in appliedenergy, impedance of the treatment location, or a combination thereof.As noted herein, such parameters may be mapped to treatment locations.It is noted that the parameters and the possible combinations mayinclude those parameters discussed in the patents listed above.

The benefits of the systems and methods described herein allow forimproved treatment in an organ that requires treatment at multiplelocations or repeat treatments. For instance, generation of thetreatment history profile and presenting the parameter data as describedherein allows a medical practitioner to potentially avoid overlappingtreatment locations or over-treating a particular location. In avariation of the invention, the treatment system may be configured toprevent providing therapy to a particular site if the map and associatedparameter(s) indicate that the device is in a location that waspreviously treated. In such cases, the appropriate audio or visualsignals will be shown on either display 130, 132.

Additional benefits include spacing treatment sites at desired intervalsand giving a signal to the medical practitioner as to when the device isin the proper location. Moreover, the systems of the present inventionmay also allow for treatment planning by calculating the shortestdistance traveled to give an indication of the next area where themedical practitioner should treat. To accomplish this, the system 10 mayprovide the appropriate instructions on the displays 130, 132. Forexample, FIG. 6E illustrates a variation of a virtual display 132. Theinformation displayed 131 is for exemplary purposes only. Variations ofthe invention include display of any of the parameters discussed herein.

As shown in, FIG. 6E, the virtual map 136 can track the progress of thedevice 18 as it advances through the organ. The virtual map 136 may alsovisually differentiate treated areas (for example, the shaded portion146) from untreated portions. In addition, the virtual map 136 mayprovide visual information to guide the practitioner to the next site(e.g., via arrow 148). In addition, the virtual map 136 may presentinformation 131 regarding parameters based on the location of the device18. For example, upon moving to the shaded portion 18 informationregarding those treatment parameters would be shown.

The system may allow a user to gain information about where they are,where they've been, and what they've done in different locations.Furthermore, to protect against inadequately treated areas, a secondpass of the device, when combined with the map and positioninginformation, may allow an evaluation of the areas that were not treated,or were inadequately treated. The system may allow for a post treatmentanalysis where the actual treatment is compared to an “ideal procedure.”

In some variations, the controller and/or power supply may be configuredsuch that it will not be able to provide a treatment if the maptreatment history profile indicates that the practitioner is about tounintentionally treat a site twice. In some variations, the system maybe combined with an auditory signal to indicate some relationshipbetween the current treatment location and the treatment historyprofile. For example, the auditory signal may give a warning noise ifthe treatment was incomplete/already performed and every time thelocating implement passes over that particular site, the same signalwould be triggered.

The treatments may also be titrated based on analysis of the map or onthe analysis of other anatomical data. For example, if the map yields anorgan having varying wall thicknesses, algorithms may be used to tailorthe parameters of the treatment (e.g., thicker walled sections receivinghigher energy treatment and thinner sections receiving lower energy.)The titration may be based on the depth at which the intended targetresides. For example, if smooth muscle tissue is located deep within theorgan walls, the titration may adjust energy parameters for optimaltreatment. In another example, the energy parameters may be reduced ifthe mapping or other analysis indicates that the target area isproximate to another vital organ.

The system of the present invention may also provide a visualidentification of the organ or area to be treated. For example, if asite has already been treated, the organ may be shown in a particularcolor and to signal an area that has not been treated, the target organmay be shown in another color. If the system determines that aparticular site should be treated next, this suggested treatmentlocation may also be visually distinguished on the visual displays 130,132.

The system may also allow for the generation of an ideal procedure orprocedure profile based on the map. For example, use of the map mayallow various characteristics to be determined about the target area ororgan (e.g., diameter of the passage, amount of smooth muscle tissue,bifurcations, etc.). Based on these characteristics, the energytreatment may be tailored for a set of ideal parameters. Therefore, amedical practitioner may compare the parameters of the actual treatment(using the treatment history profile) to the ideal parameters based onthe ideal procedure. In the case of discrepancies, the medicalpractitioner has the option to retreat areas or simply observe areaswhere actual treatment differs from an ideal treatment. The idealparameters may be the same type of parameters as those described above.For example, they may include an ideal treatment time, idealtemperature, ideal energy, ideal rate of change in temperature, idealrate of change in energy, ideal impedance of the treatment location, anda combination thereof. The system may allow for comparison of an idealprocedure to the actual procedure may occur during the procedure orafter the procedure.

As noted above, the map may permit analysis of the body and structuressurrounding the target area for improved treatments. In one example, thesystem may use algorithms for analyzing the body to determine ananatomical characteristic of the area being treated. For example, theanatomical characteristic may include the luminal passageway diameter,branching points of the organs, depth of smooth muscle tissue, amount ofsmooth muscle tissue, wall thickness of the organ, proximity of theorgan relative to a separate organ, periphery of the organs, degree offluids in the organ, number of folds in the organ, condition of anepithelial or endothelial layer in the organ, fluid flow in the organ,presence of additional tissue in the organ, presence of vessels,presence of cartilage, and degree of contraction when the smooth muscleis stimulated. Such anatomic characteristics may be identified duringthe rendering of the map as shown in FIG. 6C.

Apart from creating an ideal procedure, the procedure may be adjusted ina real time basis in response to the particular anatomical feature thatis identified on the map. When the treatment device is placed on anactual treatment site, this system may trigger the control system toalter one or more of the energy parameters.

It should be noted that the map may be constructed to be athree-dimensional map (for example, the bronchial passages branch inmany directions requiring a three dimensional map for proper imaging.)Alternatively, it may be desired to only generate a map of a singleplane.

In another variation of the invention, the aspects of the above systemsdescribed herein may be combined with a device having an energy deliveryportion that is used to apply energy therapy to the treatment location,and where the treatment device transmits information to the renderingsystem to generate at least a portion of the map as it advances throughthe network of organs. In such a case, the rendering system may simplytrack the movements of the device in the body. For example, the devicemay comprise a sensor assembly similar to that used in optical trackingdevices (such as an optical computer mouse.) In this manner, the map isrendered as the treatment progresses.

For example, a sensor assembly on or connected to the treatment devicemay be in communication with the rendering system and allow fordetection of movement of the device within the organs to generate theportion of the map. In one variation, the sensor assembly as shown by140 in FIG. 6D, may comprises a light emitting source, a sensor, and adigital signal processor where the light emitting source reflects lightoff of a wall of the organ to the sensor and the sensor transmits aplurality of images to the digital signal processor which determinesmovement of the device by comparing images, intensities, and/orwavelengths of the reflected light. As an example, the light emittingsource may comprises a light emitting diode and the sensor may comprisea complimentary metal-oxide semiconductor (CMOS). However, any knownconfiguration may be used. In some variations, the configurations maypermit tracking as the device advances through the network of organs. Anexample of the placement of the sensor assembly may be found on FIG. 6C.In most cases, the sensor assembly and locating implements will be foundon the distal ends of the devices.

In those cases where it is difficult to generate a 3 dimensional map,the treatment device further includes at least one locating implementthat communicates with an external locating system to generate theportion of the map allowing for a 3 dimensional construction.

In yet another variation of the invention, the invention includes amethod of creating a map in a network of connected organs, each having aluminal passageway, the method comprising advancing a device into thenetwork of organs, where the device comprises a light emitting source, asensor, and a digital signal processor; generating data to characterizemovement of the device in the network of organs where the light emittingsource reflects light off of a wall of the organ to the sensor and thesensor transmits a plurality of images to the digital signal processorwhich determines movement of the device by comparing images; andtransmitting the data to an electronic storage means.

With regard to the above detailed description, like reference numeralsused therein refer to like elements that may have the same or similardimensions, materials and configurations. While particular forms ofembodiments have been illustrated and described, it will be apparentthat various modifications can be made without departing from the spiritand scope of the embodiments of the invention. Accordingly, it is notintended that the invention be limited by the forgoing detaileddescription.

What is claimed is:
 1. A method for treating a lung, the methodcomprising: generating a virtual map of airways of a lung using arendering system; stimulating smooth muscle adjacent an airway of thelung to contract the smooth muscle; analyzing the virtual map todetermine a degree of contraction of the smooth muscle; applying anenergy therapy to tissue adjacent to the airway based on the determineddegree of contraction of the smooth muscle; and automaticallypreventing, with a controller, application of a subsequent energytherapy to a given portion of the airway when the subsequent energytherapy is demanded by an operator and when the controller determinesthe given portion of the airway has already received an energy therapy.2. The method of claim 1, wherein applying an energy therapy to tissueincludes determining one or more parameters of the energy therapy basedon the determined degree of contraction of smooth muscle from thevirtual map, wherein the one or more parameters include one or more of atime of the energy therapy, a time between energy therapies, and atemperature to be achieved during the energy therapy.
 3. The method ofclaim 1, further including displaying the virtual map.
 4. The method ofclaim 3, further including capturing an image of the airway with animaging device, and displaying the image concurrently with the virtualmap.
 5. The method of claim 1, wherein the rendering system includesultrasonic imaging, computer aided tomography (CT), magnetic resonanceimaging (MRI), or positron emission tomography (PET).
 6. The method ofclaim 1, further including generating a treatment history profile whichincludes each treatment location where energy therapy was applied. 7.The method of claim 1, wherein the energy therapy is applied with adevice having at least one locating implement that communicates with alocating system to establish a virtual position of the device on thevirtual map.
 8. The method of claim 7, further including displaying thevirtual map, wherein displaying the virtual map includes imposing thevirtual position of the device on the virtual map.
 9. The method ofclaim 1, wherein generating a virtual map of airways of a lung using arendering system includes compiling a plurality of images of the airwaysof the lung.
 10. The method of claim 9, wherein the virtual map isthree-dimensional.
 11. A method for treating a lung, the methodcomprising: generating a virtual map of airways of a lung using arendering system; stimulating smooth muscle adjacent an airway of thelung to contract the smooth muscle; analyzing the virtual map todetermine a degree of contraction of the smooth muscle; determining aprocedure profile based on the determined degree of contraction of thesmooth muscle, wherein the procedure profile includes at least onetreatment location; applying an energy therapy, with an energy deliverydevice, to the at least one treatment location; and automaticallypreventing, with a controller, application of a subsequent energytherapy by the energy delivery device when the subsequent energy therapyis demanded by an operator when the controller determines that theenergy delivery device is located at the at least one treatment locationwhere the energy therapy was already applied.
 12. The method of claim11, wherein determining the procedure profile includes determining oneor more parameters of the energy therapy to be applied at the at leastone treatment location, wherein the one or more parameters include oneor more of a time of the energy therapy, a time between energytherapies, and a temperature to be achieved during the energy therapy.13. The method of claim 11, wherein the rendering system includesultrasonic imaging, computer aided tomography (CT), magnetic resonanceimaging (MRI), or positron emission tomography (PET).
 14. The method ofclaim 11, further including displaying the virtual map.
 15. The methodof claim 14, further including capturing an image of the airway with animaging device, and displaying the image concurrently with the virtualmap.
 16. A system for treating a lung, comprising: an energy deliverydevice; and a controller configured to: generate a virtual map ofairways of the lung; analyze the virtual map to determine a degree ofcontraction of smooth muscle after the smooth muscle is stimulated tocontract; determine one or more parameters of an energy therapy based onthe analysis; apply the energy therapy, with the energy delivery device,to at least one treatment location; and automatically preventapplication of a subsequent energy therapy at the at least one treatmentlocation where the energy therapy was already applied, when thesubsequent energy therapy is demanded by an operator.
 17. The system ofclaim 16, wherein the one or more parameters include one or more of atime of the energy therapy, a time between energy therapies, andtemperature to be achieved during the energy therapy.
 18. The system ofclaim 16, wherein the energy delivery device includes an expandablebasket.
 19. The system of claim 16, further including at least onelocating implement coupled to the energy delivery device thatcommunicates with the controller to establish a virtual position of thedevice on the virtual map, wherein the controller is further configuredto display the virtual map on a display device coupled to thecontroller, and impose the virtual position of the energy deliverydevice on the displayed virtual map.